Tag Archives: Rx

New Blog Post and Whitepaper…and Upcoming Presentation

For those of you that have followed me here, I thought I would share three things with you:

  1. I just had my first blog post published under the Deloitte brand on the Deloitte Center for Health Solutions blog.
  2. I recently helped lead the creation of a whitepaper on what topics health plans and payers should be working with their PBMs to address.
  3. I will be speaking on the topic of specialty pharmacy at the PCMA event in March.  I hope to see some of you there.
Advertisements

Gilead’s Sovaldi Is The $5.7B Canary In The Coal Mine For Specialty Medications

In case you haven’t been tracking specialty drug costs for the past decade, the recent news with Gilead’s Sovaldi ($GILD) is finally making this topic a front page issue for everyone to be aware of.  I think Dr. Brennan and Dr. Shrank’s viewpoint in JAMA this week did a good job of pointing that issue out.  They make several points:

  • Is this really an issue with Sovaldi or is this an issue with specialty drug prices?
  • Would this really be an issue if it weren’t for the large patient population?
  • Will this profit really continue or are they simply enjoying a small period of profitability before other products come to market?
  • Based on QALY (quality adjusted life years) is this really quick comparable cost to other therapies?

If you haven’t paid attention, here’s a few articles on Sovaldi which did $5.7B in sales in the first half of 2014 and which Gilead claims has CURED 9,000 Hep C patients.

But, don’t think of this as an isolated incident.  Vertex has Kalydeco which is a $300,000 drug for a subset of Cystic Fibrosis patients.  In general, I think this is where many people expected the large drug costs to be which is in orphan conditions or massively personalized drugs where there was a companion diagnostic or some other genetic marker to be used in prescribing the drug.

The rising costs of specialty medications has been a focus but has become the focus in the PBM and pharmacy world over the past few years.  This has led to groups like the Campaign for Sustainable Rx Pricing.  Here’s a few articles on the topic:

Of course, the one voice lost in all of this is that of the patient and the value of a cure to them.  Many people don’t know they have Hepatitis C (HCV), but it can progress and lead to a liver transplant or even ESRD (end state renal disease) which are expensive.  15,000 people die each year in the US due to Hep C (see top reasons for death in the US).  So, drugs like this can be literally and figuratively life savers.  These can change the course of their life by actually curing a lifetime condition.

This topic of specialty drug pricing isn’t going away.

At the end of the day, I’m still left with several questions:

  1. What is the average weighted cost of a patient with chronic Hep C?  Discounted to today’s dollars?  Hard dollars and soft dollars?  How does that compare to the cost of a cure?
  2. What’s the expected window of opportunity for Gilead?  If they have to pay for the full cost of this drug in one year, that explains a lot.  If they’re going to have a corner on the market for 10-years, that’s a different perspective.  (Hard to know prospectively)
  3. For any condition, what’s the value of a cure?  How is that value determined?  (This is generally a new question for the industry.)

And, a few questions that won’t get answered soon, but that this issue highlights are:

  1. What is a reasonable ROI for pharma to keep investing in R&D?
  2. What can be done using technology to lower the costs of bringing a drug to market?
  3. For a life-saving treatment, are we ready to put a value on life and how will we do that?
  4. What percentage of R&D costs (and therefore relative costs per pill) should the US pay versus other countries?

The Era Of The Two-Tier PBM Strategy

After Aetna, Cigna, and Wellpoint all moved into different PBM relationships with CVS Caremark, CatamaranRx, and Express Scripts, it certainly marked the end of much of the debate on whether a captive PBM (i.e., owned and integrated with the managed care company) could compete with the standalone PBMs.  There are really only a few big integrated models left including Humana, OptumRx (as part of UHG) and Kaiser with Prime Therapeutics having a mixed model of ownership by a group of Blues plans but run as a standalone entity.  Regardless of where the latest Humana rumors take them, it made me think about what the market has become with these new relationships.

  1. Scale matters.  All of these relationships and discussions show that there are clear efficiencies in the marketplace.
    1. Drug procurement (i.e., negotiating with the manufacturers (brand and generic) and the wholesalers)
    2. Pharmacy networks (i.e., getting the lowest price for reimbursement with the retail pharmacies)
    3. Rebating (i.e., negotiating with the brand and specialty drug manufacturers for rebates)
  2. Outcomes matter.  If scale was all that mattered, there be no room for others in the marketplace.  But, we continue to see people look at this market and try to make money.  That means that “outcomes” matter in different ways:
    1. Clinical outcomes (i.e., does the PBM have clinical programs or intervention strategies that improve adherence and/or can demonstrate an ability to lower re-admissions or impact other healthcare costs?)
    2. Financial outcomes (i.e., does the PBM have innovative programs around utilization management (step therapy, prior authorization, quantity level limit) or other programs like academic detailing that impact costs?)
    3. Consumer experience (i.e., does the PBM’s mail order process or customer service process or member engagement (digital, call center, etc) drive a better experience which improves overall satisfaction and overall engagement…which drives outcomes?)
    4. Physician experience (i.e., does the PBM engage the physician community especially in specialty areas like oncology to work collaboratively to drive different outcomes?)
    5. Data (i.e., does the PBM use data in scientifically valid but creative ways to create new actionable insights into the population and the behavior to find new ways of saving money and improving outcomes?)

While I’ve been beating the drug of the risks of commoditization to the market for years, I’m going to make a nuanced shift in my discussions to say that there is still a risk of commoditization and driving down to the lowest cost, but we may be quickly approaching that point.  What I’m realizing is that there can be a two tier strategy where you commoditize certain areas of the business and let the other areas be differentiated.  And, that this can be a survival tactic where you either outsource the core transactional processes to one of these low cost providers or figure out how to be one of them while creating strategic differentiation in other areas.  

Maybe you can eat your cake and have it too!

Image

Getting To Zero Trend In Specialty Pharmacy – CVS Caremark – AHIP

When I was at AHIP last week in Seattle, I had a chance to see Alan Lotvin from CVS Caremark present on specialty pharmacy.  It was one of the best presentations that I’ve seen in a while.  

It was good because I actually heard things that I’d never heard discussed around specialty pharmacy before.  And, as he pointed out, specialty will represent 50% of the pharmacy spend and about $235B in total spend by 2018.  This is where everyone is focused and the opportunity for differentiation exists. 

  1. He talked about how to get to zero trend in specialty.
  2. He talked about the consumer experience in specialty.
  3. He talked about care coordination and its value in specialty.
  4. He talked about the need for a beyond the pill approach by the specialty pharmacy.

So, what does all this mean?  Let me share some highlights:

  • Specialty pricing is starting higher based on government pricing constraints.  You can’t raise price.  It’s easier to start high, discount, and/or come down over time.
  • Pharma is beginning to price based on Quality Adjusted Life Year (QALY).
  • 3.6% of patients drive 25% of costs (not a surprise)…but 43% of their total costs are not from the specialty condition but from their co-morbidities.  (Why treating the patient not the condition is critical.)
    Image
  • Site of care (which is the hot buzz today) can save you 17% or more.
  • Developing an exclusion formulary is important to counteract copay cards and help reduce costs.

o   This article says that CVS Caremark is working on a formulary with 200 brand drugs excluded.

  • They are moving from 12-month contracting with pharma to 2-3 month contracts to really keep on top of market conditions. 
  • Coordinated care can drive lower costs in terms of readmissions and other total medical costs. 
  • You can use generics to replace biologics.  For example, he showed switching out an HIV biologic costing almost $3,000 / month with 3 generics costing $101 per month.  (I’ve never heard anyone else talk about this.)
  • He also reinforced the fact that today’s specialty benefits are not coordinated across medical and pharmacy.  For example, he used the RA example where there are 9 drugs with 4 of them commonly used under the medical benefit and 5 under the pharmacy benefit. 

But, the most important thing was their strategy to get clients to ZERO TREND for specialty pharmacy.  (It reminded me of the program I developed at Express Scripts where we actually guaranteed a 3-year zero trend…if you followed our very aggressive recommendations.)  He outlined the following:

  • 1.5% savings from their formulary
  • 0.5% savings from an exclusive specialty network
  • 1.9% savings from an aggressive generic policy
  • 1.0% savings from innovative pricing
  • 3.6% savings from optimizing site of care
  • 2.5% savings from medical claims editing and repricing
  • 6.0% savings from enhanced prior authorization

He also went on to talk about the consumer experience.  I think a lot of specialty pharmacies are thinking about the same things, but there were several things he shared that were new to me.  It was exciting. 

As I’ve said before, as specialty pharmacies really start to think about the patient and focus on the experience over time, we will start to see more coordination with pharma about going beyond the pill and driving lower total costs.  

19% Higher Risk Of Medication Non-Adherence If The Physician Communicates Poorly

This was just one of the really great data points I got from the Medication Adherence Clinical Reference page from the American College of Preventative Medicine.  It’s worth a read.  

But, let me highlight a few other points:

  • Non-adherence is thought to account for 30-50% of treatment failures.
  • Trust and communication are critical factors in adherence.

I think this is important because a lot of the industry solutions focus on the pharmacy and the consumer.  They don’t (IMHO) go back to the initial discussion with the provider.  How are we helping to enable those conversations to last longer than 99 seconds in the average encounter in which time they have to explain the medication, the side effects, and help the patient feel like the medication is going to make a difference?  (Of course, this always make me think of my favorite placebo effect video.)

 

Additionally, this chart from the Adult Meducation publication was a great list of factors reported to impact adherence.  (Sources: Miller et al., 1997; Nichols-English and Poirier, 2000; Vermiere et al., 2001; World Health Organization, 2003; Krueger et al., 2005; Osterberg and Blaschke, 2005)

Image

They also share this chart (which I’ve seen a version of many times):

Image

[Source: National Association of Chain Drug Stores, Pharmacies: Improving Health, Reducing Costs, July 2010. Based on IMS Health data]

 

 

New CVS Caremark Offering – Specialty Connect

First CVS Caremark began offering mail order (90-day Rxs at lower cost) at retail stores (aka Maintenance Choice), and now with Specialty Connect, they are doing the same thing in specialty pharmacy.  

Specialty Connect was a pilot program that won the PBMI Innovation Award this year.  What it does is to allow consumers the choice of getting their specialty medications at either the CVS Caremark specialty pharmacy or picking them up at a local store.  This is a change since: (1) many pharmacies don’t typically stock specialty medications; (2) many PBMs require use of a specialty pharmacy (i.e., mail); and (3) specialty medications typically require some addition handling and counseling which may be difficult to do at a local store level.

But, this is a very consumer friendly solution, and it has had some positive initial success.  Here’s a quote and some data from their press release: (some additional data in the original PBMI document)

“Specialty Connect helps specialty patients with these critical therapies by helping to eliminate common challenges they had often faced and by offering them flexibility and choice,” said Alan Lotvin, M.D., Executive Vice President of Specialty Pharmacy for CVS Caremark. “The program makes it easier and more convenient for patients to submit and receive their specialty prescriptions either through CVS/pharmacy or by mail. What’s more, it increases medication adherence, improves outcomes and lowers overall health care costs for specialty patients and payors.”

 

Specialty Connect has demonstrated high levels of patient satisfaction as well as improved adherence for specialty pharmacy patients. In fact, pilot program results demonstrated a 13 percentage point increase (from 66 to 79 percent) in patients who were optimally adherent to their medication. Early program results also show that the program is improving upon the patient experience and reducing traditional barriers to getting started on medication, with 97 percent of patients successfully starting on therapy after only their first interaction at a CVS/pharmacy store. In addition, more than half of patients, many of whom were existing mail service pharmacy customers, chose to pick up their specialty medications at CVS/pharmacy.

Hopefully, this and many of the other CVS Caremark successes will make people wonder why they ever wanted to break the company up into different business units.  As I’ve said for years on the blog, in the press, and to many Wall Street analysts, the integration of the business units can offer huge value once the synergies are realized and the consumer experience is integrated.  

The other interesting things that I thought about when reading about Specialty Connect were:

  • It’s great to offer a centralized call center to support specialty but will that be enough at the local store level?  Will patients want some type of higher touch local presence?  Can that be achieved through a telemedicine or kiosk type solution?  
  • I remember about 5 years ago when most specialty people thought they had to treat patients with specialty diseases differently.  I kept trying to argue that they are just like other consumers.  You should think about the experience across channels and at the patient not just condition level.  This seems to signal a movement towards this.  They are using SMS (text messages) and other channels to communicate with them which was a foreign concept a few years ago.

Care Is Coming To Your PBM

The creation of the “softer, gentler” PBM is one of my predictions driven by the rise in specialty pharmacy. While generic fill rates and mail order penetration still matter to earnings, the focus across the industry is on specialty. 

  • What can we expect in terms of pipeline?
  • How and when will genetic tests be required? (i.e., companion diagnostics)
  • How can we treat the patient not just fill the drug?

This will bring back a focus on how pharma and the PBMs work together which has had a bumpy past. Initially the two were very close. Then, with the rise of generics and more trend programs like prior authorization and step therapy, the PBMs and pharma butted heads frequently.

Of course, the situation for pharma has changed also. They are trying to figure out how to go “beyond the pill” and create new consumer relationship and make money. (Here’s a good article about pharma and digital from the other day.)

In case you missed them, here’s a few other things that are relevant:

And, I think this screenshot from the Barclays Global Healthcare Conference Presentation given by Express Scripts shows that they are focused on this care and delivery intersection by continuing to show the success from the Therapeutic Resource Centers.

Image

So, what do you think?  Will the PBMs become more care management focused?  Will they integrate with the other care providers?  Will this be the beginning of their focus on working with ACOs and PCMHs?  Will this change their approach?  Will we see PBMs differentiating around key, chronic diseases like the specialty pharmacies have done?  Will this create an opportunity for integrated PBMs (i.e., Humana, Cigna, Aetna) to differentiate?  

CVS Caremark 2013 Drug Trend Report (Insights 2014)

The CVS Caremark publication Insights 2014: Advancing The Science Of Pharmacy Care came out the other day. They took a different approach than the detailed trend report which Express Scripts put out.  Their document is more of a white paper about “7 Sure Things”.

The 7 Sure Things are to help you know what to do with your pharmacy benefit and cover:

  1. Prescription trend is on the rise.
  2. Generics have peaked…and you’re going to feel the difference.
  3. Specialty drives trend.  But do you know how much?
  4. Price is King…Not much of a surprise there.
  5. Money matters to members.  Cost share does influence behavior.
  6. Adherence is the answer.  No one said it was going to be easy.
  7. Past performance is no guarantee of future results.

If you’re managing a pharmacy program and you’re surprised by any of these, I would suggest you look for another job.

So, let’s drill down into the report to see what it shows us:

  • Their trend numbers were:

o   0.8% for traditional (non-specialty) drugs

o   15.6% for specialty drugs (down from 18.3% in 2012)

o   3.8% overall

  • While utilization was up 2.1%, the primary driver was price which increased 8.2%.  These factors were mitigated by a 6.0% change in mix.

o   They hint at an interesting question of whether utilization is growing due to an improving economy.  (correlation or causality?)

CVS Caremark Drug Trend 2013

  • Their GDR (generic dispensing rate) was 81.4% in 2013.  (I’d love their perspective on a maximum GDR since they say it’s peaked.)
  • I like the chart below which shows trend with and without generics coming to market.

CVS Caremark DTR 2013 -trend wo generics.jpg

  • Of course, specialty continues to be the real story in all the PBM reports.

CVS Caremark DTR 2013 -specialty.jpg

  • They claim that 53% of total specialty medication costs were paid under the medical benefit in 2012 which is in-line with most projections.  (While they give some perspective on what to do here, this would be one thing I would have liked to see broken out in more detail as this is a critical area for PBMs which hasn’t been cracked yet.)
  • They share the AWP trend broken out below and give some crazy examples of AWP price inflation (e.g., 573% for clomipramine) with some explanation for why this happens.

CVS Caremark DTR 2013 -awp trend.jpg

  • Here were their top 10 specialty drug categories.  The top 5 are the same as the CatamaranRx list, but the bottom 5 are in a different order.

CVS Caremark DTR 2013 -top 10 specialty.jpg

  • A scary statistic (in isolation) is that over the past 5 years patient out-of-pocket costs for prescriptions have climbed 250%.  (But, I think their percentage of cost share has stayed the same.  It would be interesting to show this in real dollars and compare this to both price and wage inflation just to hammer home the point.)
  • They talk about CDHPs (consumer driven health plans) and how that is impacting utilization and cost.  (These are often high deductible plans where consumers pay out of pocket until they reach a certain amount…which often really makes the point in early January to consumers.  And, can lead to dissatisfaction when that prescription that was $30 in December is now $350 in January.)
  • They talk about adherence, and they certainly have continued to publish a lot of studies in this space.  (They also know have Dr. Will Shrank on their staff full-time after working with him for years.  I think very highly of Will as one of the best adherence researchers in the country.)
  • They give a real high level mention of some of their new efforts around adherence:

o   Simpler labels

o   Synchronizing refill dates

o   Reminder devices

o   Digital / mobile tools

  • They also provide this nice summary of how costs go up and where the savings come from.  (Of course, the challenge is in drug classes other than these three and getting clients to give you any credit for the productivity savings and also netting out the program costs.)

CVS Caremark DTR 2013 - adherence value.jpg

  • On a scary note, they predict that Rx trends may jump back into the double digits for the next 4 years.

At the end, they give 5 sure strategies that clients should do.

  1. Double down on generics.  (To me, this means – step therapies, formularies, setting copays right, mandatory generic programs, and generic substitution programs.)
  2. Look across benefits at specialty.  (This is a key one as I mentioned above.  You need to think through how specialty drugs are filled and billed under medical.)
  3. Tackle price.  (They are focused on distribution channel here, but I’d also think about copay levels, plan design, and value-based programs.)
  4. Be strategic about cost share.  (They are focused on how cost share affects adherence which is important, but only one component of an adherence strategy.)
  5. Keep the big picture in mind.  (They allude to it here, but I think this is a key point that ultimately it’s about outcomes and prevention.)

Overall, this was certainly the easiest “trend report” to read. It tells a clear story which is probably great for the average client and would drive more discussion with your account manager.

2013 CatamaranRx Drug Trend Report

I just finished reading the 2013 CatamaranRx Drug Trend Report (2014 Informed Trends: Moments of Opportunity) and wanted to share some of the things that caught my eye. (BTW – CatamaranRx was formed by the merger of SXC and CatalystRx.)

One of the early comments in the document caught my eye. While simple, it is still so true in healthcare.

“Bringing consistency through a national perspective on best practices, a “local” understanding of how health care is practiced and deep insights at the individual level, to promote the very best outcomes.”

CatamaranRx Trend

  • They did a good job of tackling the impact of healthcare reform on the PBM marketplace and why this creates more opportunities.

“The looming pharmacy demand is also driving the healthcare market toward expanded cost containment and coordinated care measures. Industry estimates are projecting more than 30 million new PBM customers as a result of the ACA. This influx of new customers will stimulate creative cost management paradigms and entice new entrants into the PBM sector.”

  • 50% of the new drugs approved by the FDA in 2013 were specialty drugs.  (reiterating the fact that specialty is really the focus of the PBM today in terms of opportunity to influence trend)
  • 30% of the new drugs approved were oncology drugs.  (similar to years past)
  • Orphan drugs without competition were 2.6x more expensive than orphan drugs with competition.  (not too surprising)
  • They point out that no true biosimilar has been approved in the US (which I didn’t realize).  They also point out that international experience is that biosimilars will save 10-15% not the 40% projected by the CBO.
  • They have nice clean charts around price inflation (deflation) for brand and generic drugs.

2013 CatamaranRx Brand Rxs

2013 CatamaranRx Generic Rxs

  • The average cost of a specialty drug rose to $2,860 in their book-of-business.
  • The top 10 specialty drug classes represent 86% of specialty drug spend.

2013 CatamaranRx Top Specialty Classes

  • The report talks about medication adherence using PDC (proportion of days covered).  They show some good adherence rates in key classes (which always brings up questions about methodology).

o   Over what time period?

o   Is this all members prescribed an Rx?

o   Is this all members with one Rx?

o   What is the percentage of members with over 80% PDC (versus the average PDC)?

o   (Note: These are the same questions for every PBM that shows you adherence numbers.)

  • Here’s their forecast for the next few years in terms of trend.

2013 CatamaranRx Trend Forecast

  • They are projecting a generic fill rate of as high as 90% by the end of 2016!
  • I like that they break out their highly managed clients to show they got an overall trend of -0.1% even though they had higher specialty trend driven by oncology.  They shared a list of key things that those clients were doing:

o   Member risk scoring and personalized interventions.

o   Tailored clinical programs, including step therapy, quantity limits and prior authorization.

o   Aggressive management of controlled drugs to reduce misuse and abuse.

o   Formulary management tailored to address client-specific, high-cost medication classes.

o   Exclusive specialty through BriovaRx, a high-touch, patient-centric model.

o   Plan designs with copay differentials that promote cost-effective choices.

o   Multi-channel communications that engage members in their healthcare.

  • I was excited to see them dedicate a whole section talking about engagement.

o   The need for the right message.

o   The need for targeting algorithms.

o   The need to vary channel based on preference.

  • They share some details on their hospital discharge program which sounds right from a PBM perspective – focused on medication reconciliation and adherence.  My key question would be understanding if they address the other risks of re-admission while they have the patient on the phone (i.e., treating the patient not the Rx and not the disease).
  • I haven’t heard as much about MTM lately so it was nice to see them talk about it and see some results which seem really good.

2013 CatamaranRx MTM

Two miscellaneous comments here:

  1. This seems to be a much improved document than the one I reviewed years ago from SXC.
  2. My only challenge with the format was that it prints the two pages on one page in the PDF (but that could be user error).

Express Scripts 2013 Drug Trend Report

I always enjoy reviewing the PBM Drug Trend Reports.  Even though these past two years I’ve been focused more on the care management side of healthcare, I continue to see these two paths colliding in interesting ways in the near future. 

Here’s my big takeaways from the report some of which you can get in their Executive Summary

(I’d also encourage you to look at Adam Fein’s review…where he unfortunately beat me to the punch again.)

  • Overall trend was 5.4% which they did a nice job of breaking out according to different lines of business.
    ImageImageImage
  • They also showed the breakout of trend comparing specialty drug trend versus traditional oral solid medications. 

 Image

  • Specialty trend was up 14.1% based on a 2.5% increase in utilization and an 11.6% increase in unit cost.
  • A key point is that specialty now makes up 27.7% of the total drug spend for a payer (and that doesn’t even count the ~50% of specialty drugs billed under the medical benefit).
  • Diabetes was the standout category within traditional drug classes with increased utilization and price increases.  [Which isn’t surprising to those of us working on the clinical side that see huge innovation and investment in the diabetes area – Omada Health, Telcare, and Welldoc (for example).]
    Image
  • While they make a key point with data that member cost share is going down and actual out-of-pocket costs are only going up marginally, I think it ignores the reality that consumers are feeling the pain of out-of-pocket spending more especially with all the High Deductible plans out there.
    Image
  • They do reinforce their previous messaging around waste and also introduce their Health Decision ScienceTM approach.  (I personally would have liked to see more on this.  How is the blending of Consumerology and the Therapeutic Resource Centers impacting utilization, adherence, waste, clinical outcomes, patient satisfaction, or other key metrics?)
  • As always, you can dig into their forecasts by drug class.  I choose cancer as one area to look at.  (While this is focused on the basics, I would have loved more about what’s going on around cancer.  How are genetic tests impacting use?  What about survivorship?  How do Centers of Excellence affect outcomes, drug selection, pricing, and adherence?)
  • On top of being able to drill down on Medicare and Medicaid, you can also look at a Worker’s Compensation specific version of the drug trends.  This is interesting since that business is different than the traditional PBM market and is an area that Express Scripts has gone aggressively after in recent years. 
  • One thing I couldn’t find in the document (which is hard to read in the current format) is the average number of Rxs PMPM or PMPY which is just a good stat that I personally track. 
  • One note I will offer on methodology is the definition of specialty drugs.  This could lead to some differences between PBMs as we try to compare their trend numbers.  Here’s the definition Express Scripts offers:

“Specialty medications include injectable and noninjectable drugs that are typically used to treat chronic, complex conditions and may have one or more of the following qualities: frequent dosing adjustments or intensive clinical monitoring; intensive patient training and compliance assistance; limited distribution; and specialized handling or administration. – See more at: http://lab.express-scripts.com/drug-trend-report/appendix/methodology#sthash.dhJhFIZs.dpuf” 

 

The Case For Beyond The Pill Strategies In Pharma

You’ll hear this buzzword – “beyond the pill” – come up every once in a while in a discussion with a pharmaceutical manufacturer.  As the drug pipeline has dried up and generics have become the norm for oral solid medications, the question is how do these behemoth companies “pivot” to leverage their massive global footprints, their feet on the street, their deep disease specific insights, and their medications. 

“In population health, what once drove revenue becomes a source of cost. If products, services, and therapeutics don’t lower costs, meaningfully improve outcomes, and help better patient experience, population health managers simply won’t use them.” Jerry Cacciotti, Partner, Health & Life Sciences, Oliver Wyman (source)

I’m a big believer in this strategy.  Imagine what they could do in terms of services to wrap around obesity drugs.  Imagine how they could support patients with diabetes or with cancer.  While the short-term view is that these actions might help differentiate them from a formulary or specialty pharmacy perspective, I would argue that they might actually come out with new business models like Merck is doing with Vree Health.

Ultimately, it all begins with an understanding of several issues from the outside-in:

  • What is the patient journey?
    • How do they experience the healthcare system? (e.g., clinics, MDs, pharmacists, family)
    • How or what influences their experience? (e.g., Dr. Google)
    • How do their experiences change over time? (e.g., newly diagnosed versus chronically sick)
    • Which experiences do they remember? (or as one of my clients call it – the Golden Moments)
  • What does the patient really want or need?  (think about Maslow’s hierarchy of needs)
  • Where is the patient (especially from a digital perspective)?
  • What are the patient’s expectations for you (pharma) or another entity?
    • How do they feel about you?
    • Do they trust you?
  • How do the other constituents in the care team interact with you?  With the patient?
  • How do you create a culture of empowerment, consumer focus, and transparency to really understand the needs of different constituents, react to them internally, and embrace issues dynamically?

In this consumer experience space, I often look to Bruce Temkin’s work and research.  He does a great job at a cross-industry perspective.  In healthcare, I’ve been very motivated by the work of Ingrid Lindbergh who was at Cigna and then moved to Prime Therapeutics.  She’s my role model for what I want to do in a large healthcare company. 

Two things got me thinking about this topic.  First, I was struck this weekend that there was research showing that people who struggle to buy food for their families are non-adherent.  I really hope that anyone in this field wasn’t surprised by that fact.  Of course, the struggle is that everyone working in the field is often constrained by their view of the world which often doesn’t include much experience with poverty. 

Second, I was sent a new research piece by Accenture called “Great Expectations: Why Pharma Companies Can’t Ignore Patient Services”.  It made me think about Dennis Urbaniak’s move from Sanofi where he was leading a lot of innovation to a Managing Director at Accenture.  Perhaps, he will bring some of this type of innovative thinking to more pharma companies. 

Here’s two infographics from the Accenture report which I think help hammer home the point of why beyond the pill is necessary:

Image

Image

Listing of Medication Adherence Solutions

It’s been a few years since I’ve worked on medication adherence solutions.  It seems to have become a big focus again in the industry both with the Medicare Star Ratings program and with all the emphasis on waste.

As I started thinking about adherence, I thought it would be good to create a list of solutions and vendors.  I couldn’t find one anywhere on the web.  So, here’s my initial list of almost 100 companies.

I’ll make this a dynamic list so please comment or send me suggestions to add.

Here’s some old posts on adherence that I think are still relevant here:

I’ve divided the list of solutions and vendors into the following:

Devices

  • Adherence Solutions LLC – develop programs to create alliances between different players, sell Dose-Alert which is a smart pill bottle cap, and provide a mobile tool
  • AdhereTech – smart pill bottles
  • Automated Security Alert – medication dispensers to complement their medical alert system
  • Biodose – electronic tray for monitoring time and day of use
  • CleverCap – smart cap for pill bottle
  • Didit – manual tracking device that attaches to a pill bottle
  • DoseCue – smart pill bottle
  • eCap – electronic compliance monitor
  • ePill – medication reminder devices
  • eTect – biocompatible tag on the pill with connectivity and a mobile solution focused on clinical trial adherence
  • iRemember – smart pill bottle cap with voice reminder and smart phone synching
  • MedCenter – monthly organizer and reminder system
  • Med-E-Lert – automated pill dispenser
  • MedMinder – automated pill dispenser
  • MedVantx – medication sampling at the physician’s office
  • Proteus – smart pill technology
  • Quand Medical – uses Near Field Communications and mobile to do medication management and reminders
  • SMRxT – smart pill bottle
  • TalkingRx – audio device attached to pill bottle
  • uBox – smart pillbox
  • Vitality GlowCap – smart pill bottle with communication programs

Mobile / Digital

  • 2Comply – patient portal with web coaching
  • ActualMeds – online medication management for consumers, caregivers, and providers
  • AI Cure Technologies – digital health solution
  • AssistMed – web and mobile based adherence solutions
  • Ayogo – social games and apps to improve engagement and adherence
  • CareSpeak – mobile solution
  • Care4Today – two-way messaging platform, app, and website
  • CellepathicRx – mobile solution
  • CloudMetRx – cloud based solution to help caregivers with medication management
  • Dosecast – mobile medication management and pill reminder
  • GenieMD – mobile medication management and reminders as part of broader solution
  • iPharmacy – mobile pill identifier, medication guide, and reminder app
  • Mango Health – mobile medication management with gamification and incentives
  • Medacheck – mobile reminder system that incorporates caregivers
  • MedCoach – mobile medication management and pill reminder
  • MedHelper – medication compliance and tracking app
  • mHealthCoach – reminder based solution creating a digital support system
  • Mscripts – mobile solution
  • MyMeds – mobile and web medication management and pill reminder solution
  • MyMedSchedule – mobile Rx management tool with reminder service
  • Nightingale – mobile solutions for reminders, engaging your physician, and notifying your caregivers
  • PillBoxie – mobile medication management and reminder app
  • PillManager – mobile medication management and pill reminder
  • PillMonitor – mobile medication reminders and logs
  • PillPhone – mobile phone solution with biometric authentication
  • Prescribe Wellness – automated, digital interventions
  • RightScript – platform to manage prescriptions through mobile reminders that connect patients, caretakers, practitioners, and health plans
  • RxCase Minder – mobile medication management
  • RxNetwork – mobile medication management and reminders with rewards
  • Quintiles – building digitally, connected communities
  • Virtusa – multi-dimensional interventions across the patient’s journey

Platform

  • Adheris – adherence suite and advanced analytics (just acquired Catalina Health) [note: they are owned by inVentiv Health who I work for]
  • Avanter – an adherence program for pharmacies in Argentina
  • Capzule – pill reminders as part of PHR
  • Dr. First – embedded tools into EHR
  • HealthPrize – platform with gamification, incentives, education, and communications
  • LDM Group – suite of compliance products
  • McKesson – sampling, coaching, coupons, and messaging
  • MediSafe – mobile medication management app and adherence platform
  • MedPal Health Solutions – platform for medication adherence solutions
  • MedSimple – medication management, pill reminders, coupons, and PAP programs
  • mHealthCoach – care collaboration platform using machine learning to personalize communications
  • Tavie – virtual nurse for improving adherence focused on several conditions

Communications

  • Ateb – multi-channel communication programs for pharmacies
  • Atlantis Healthcare – custom adherence solutions
  • Eliza – multi-channel communication programs
  • Intelecare – multi-channel adherence communications
  • MemoText – messaging platform
  • Patient Empowerment Program – medication adherence program for pharmacies
  • Pleio – adherence solutions for the first 100-days (when most people stop taking medications)
  • Silverlink – multi-channel communication programs [note: this is the company that I used to work for and still use]
  • Varolii (now Nuance) – multi-channel communication programs
  • Voxiva – web and text messaging solution
  • West – multi-channel communication programs

Big Data

Tools / Enablers

  • 5th Finger – assessment and personalization tools
  • GNS Healthcare – using data and predictive models to identify targets and fuel intervention programs
  • HumanCare Systems – creating patient and caregiver support solutions
  • Insignia (PAM) – measure of patient activation for segmentation and scoring
  • MedMonk – help pharmacists obtain funding for patients who can’t afford their out-of-pocket pharmaceutical expenses
  • MedSked – low tech, high impact labeling solution
  • Merck Adherence Estimator – screening tool available as a widget or online at Merck Engage
  • NaviNet – communications network to enable adherence
  • NCPA – toolkit and ROI calculator for pharmacies
  • ScriptYourFuture – tools and text reminders
  • Walgreens API – an application programming interface for developers to use to connect their adherence solutions to Walgreens

Medicare focused

  • Dovetail – pharmacist led programs including MTM, in-home visits, and telephonic coaching (focused on Star Ratings)
  • Mirixa – incorporated into the MTM program
  • Outcomes – data and tools as part of their MTM solution
  • Pharm MD – Medicare STARS program

Condition specific

  • GeckoCap – adherence offering for kids with asthma
  • MyRefillRx – mobile adherence app focused on high blood pressure

Packaging

Pharma

  • 90Ten Healthcare – providing adherence programs in 23 countries
  • TrialCard – voucher and co-pay programs for consumers to stop Rx abandonment
  • Triplefin – customized programs for pharma brand managers
  • Adherence Engagement Platform – a Pfizer program of adherence materials and tools (I couldn’t find it online only in hard copy)
  • RS Associate – a company working with manufacturers in India
  • Rx.com – MTM, pre-edit messaging at the POS, and print-on-demand messaging at the pharmacy

International (recommendations send to me without English sites)

What other companies am I missing?  Send them to me directly or add them in the comments section here.  Thanks.

How Do The Big PBMs Grow?

By now, the idea of a PBM and who they are is much more of a household item than it was a decade ago.  We’ve seen massive consolidation in the industry.  We’ve seen PBMs grow in the specialty PBM space.  The question I often ponder is what’s next.  Here’s some of my thoughts.

  1. Do Nothing.  Obviously, there’s a lot to be said for ongoing momentum.  The PBMs have shown growth for many years.  While the generic opportunity and the mail opportunity has slowed down, there are still opportunities in the specialty space.  
  2. Distribution. This seems like an obvious possibility.  Why not buy Cardinal, AmerisourceBergen, or someone else?  Procurement and distribution are core competencies so I think this makes some sense.  But, will that create issues in the current client list and retail pharmacies and PBMs haven’t always had the best relationships.  (E.g., Express Scripts GPO with Kroger)
  3. Pharma.  This has been debated by a few PBMs, but getting into the R&D space is risky and doesn’t build on their core competencies.  What could be more interesting would be them getting into the services space by acquiring a company like IMS or Quintiles.  
  4. International.  Several PBMs have tried this model.  In general, it hasn’t gone anywhere.  I think the international collaboration of Walgreens and Boots is really interesting and other retailers have gone international.  I don’t see this happening anytime soon with any material impact.  
  5. Physician.  Having a greater impact in the prescribing process could make a lot of sense.  I could see some interesting targets in terms of Allscripts, Cerner, or athenahealth.  This has been a challenge for years with a few ventures into the space.  (e.g., CVS Caremark and iScribe)
  6. Technology.  At the end of the day, the PBMs are large technology companies.  Could they see their way into the mHealth space?  This space is growing like crazy, and you’re seeing established players get into the remote patient monitoring space (e.g., AT&T and Qualcomm).  I could see an acquisition in this area of a telehealth company (e.g., Teladoc) or a device company (e.g., Welldoc).  Or, they could build something more organically.  On the flipside, they could look at technology platforms to open doors to care management or ACOs (e.g., Lumeris).  Alternative, I could see SoloHealth as a really interesting asset.    
  7. Retail.  With a few exceptions, I think this strategy is off the table.  I’ve loved the CVS Caremark integration for years, and I think it’s showing dividends.  Rite-Aid is probably the only big acquisition target out there.  In this space, you probably have to look at it the other way.  Would any retailers (e.g., Walmart, Walgreens, Target) buy a PBM?  Walgreens got rid of their PBM, and Walmart has said they don’t want to be in that market so I’m not sure that would go anywhere.  
  8. Insurer.  I think this one has some interesting opportunities from a Medicare perspective and from a commercial perspective.  Could PBMs create an underwritten product and take on risk?  I think yes, BUT I think that could impact their need for reserves and the way the market sees them.  That makes me think this is less likely, but possible.  
  9. Device Benefit Management.  I think several ex-PBM executives have gone out to try to build the “benefit management” concept into the healthcare marketplace in other areas (e.g., IPG).  Could an existing PBM do it and cross-sell into their base?  Perhaps.  But, a stretch.  They’re getting big so they want to buy meaningful revenue, create synergies, and then grow it.  
  10. Navigation.  The most used benefit is pharmacy.  Today, consumers touch the healthcare system most frequently through retail and their daily prescriptions.  With the ongoing complication of the health benefits, there is a huge need for navigators (and not just in the healthcare.gov use of the term).  Think about companies like Health Advocate or Accolade.
  11. Data.  With the RxAnte acquisition, it has to make you wonder about PBMs and their data assets.  How can they use them differently?  Can they create apps?  Can they create algorithms to license?  What would this look like?  What about companies like Proteus?  Perhaps, a PBM could consolidate several unique assets along the device, smart bottle, data path.
  12. Condition specific.  I could see some PBMs going deep on particular areas like oncology to really build out an oncology practice that did everything from second opinions to case management to end-of-life counseling.  Those could all wrap around the drugs.  Or, imagine them going into the chronic kidney care space by acquiring a company like DaVita.  
  13. Providers.  While there could be some interesting synergies here with a large hospital group (e.g., HCA) or some ACO/PCMH players, I see that more of a managed care play for rolling up companies.  The ROIC (Return on Invested Capital) is too different in these physical operations that I see that being a struggle.  And, I think there’s lots of concerns about the hospital needs over time.  

Which path plays out…I don’t know, but I think it’s getting close to time that you’ll see another shift in the market as they try to secure their next 10 years of growth by expanding into something that builds on their core competencies.  

I think the other question would be if they focus on differentiation by really showing material differences in outcomes and engagement rates and look at how they show an overall health ROI not just Rx specific.  That would be where I would place my bets and look at which of these options support that.  Maybe we’ll see a PBM X (like Google X) doing some strategic long-term deals to change the overall healthcare roadmap.  

Interview With David Tripi – Janssen Healthcare Innovation

A few weeks ago, as a follow-up to my discussion with Aetna about CarePass, I had a chance to talk with David Tripi from Janssen Healthcare Innovation about their new solution.

David is a founding partner at Janssen Healthcare Innovation where he is part of a multi-disciplinary group working toward the goal of propelling the company to become the leader in the healthcare solution business. Prior to the launch of the JHI team, David was with Johnson & Johnson for over 15 years.

“Janssen Healthcare Innovation (JHI), an entrepreneurial group within Janssen Research & Development, LLC, develops cutting-edge health solutions designed to modernize healthcare delivery, improve patient outcomes, and create a healthier world.”  This is a 3-year old effort by Johnson & Johnson focused on integrated care businesses and enabling technologies.  To support those, medication adherence and mobile are key areas.

One thing that David stressed is that they are platform agnostic and that their Care4Today Mobile Health Manager works as both an app and via SMS.  Therefore, the 50% of the US that doesn’t have a smartphone can still use it.  Additionally, it’s not a product or drug specific solution.  You can use this even if you don’t use a J&J product.

Care4Today Care4Family

Adherence is a huge challenge that everyone is aligned around, and everyone is trying to find solutions – plan design, incentives, apps, consumer engagement, framing, behavioral economics, and smart pill bottles (to name a few).  So, what’s part of the Care4Today solution?

  • It has reminders for Rx and OTC products.
  • It has a refill reminder process which they hope to automate in the future.
  • It has a two way secure messaging platform.
  • It has images of over 20,000 pills.
  • And, they also included a caregiver strategy and an incentive option.

The idea of social health is important.  We’ve talked about this for weight loss and smoking.  But, with the expanded role of caregivers, can they play a key role in improving adherence?  For example, if you respond that you didn’t take your pill and the response goes to your caregiver, will they call you?  Will that follow-up motivate you?  (Care4Family)  Some prior research says yes.

A broader question might be about how to pick a caregiver or how to define it.  Should it just be your family?  Should it include your physician?  What if you don’t have a support system?  Could the healthcare companies or advocacy companies give you a “professional caregiver”?  What about an avatar as a caregiver?

I asked about the incentive program that they included (Care4Charity).  David pointed out that using apps isn’t fun (at least for most people) so they wanted to give a slight motivation.  I questioned him on why $0.05 (which is the daily donation if you check in and take your meds).  They did lots of research which showed that the amount didn’t really matter.  So, this is an experiment to see if this extra feature of the program will nudge people to be more adherent.  Or ultimately, it would be great to segment the population to understand who it was motivating for and for whom it didn’t matter.

One of the things I wondered about was how they were going to promote the app.  Obviously, relationships with companies like Aetna and their CarePass program are one way, but with the tens of thousands of apps out there, how will people find it?  David told me that they were going to initially focus on social media – Facebook, Twitter, and mommy blogs – to drive awareness.  Next, they’re going to use pharma reps to discuss the app with physicians and pilot this strategy in HIV.

At the time, they’d had over 55,000 consumer downloads, and they’ve already gotten some initial feedback from physicians that like the fact that they’re offering solutions that aren’t branded to a specific pharmaceutical product.  Some of those physicians are already offering it to patients.  They expect this will be a big driver.  They are now starting to talk with retail pharmacies about how to encourage consumer use.  While my initial reaction was that this would be “competitive” with the Walgreens and CVS Caremark mobile solutions, they see collaboration opportunities especially with Walgreens and their open API.

Of course, I wondered about how the app was being used, but they don’t collect PII (personally identifiable information).  In the future, they plan to offer an option for patients to opt-in to share information and create a clinic dashboard for physicians to see which patients are using it and providing them with data.  And, with a new collaboration with HealthNet, consumers will be logging into the app with their HealthNet ID which will allow them to link up PII and PHI (protected health information).

So, what’s next…

  • They’ve launched in the US and France.  They’re expanding into the UK and other countries next.
  • They’re adding Spanish in Q1-2014.
  • They’ve just completed some human factor testing which will drive some UI and UX changes.
  • They’re going to do some testing and look at results with whatever data is available.
  • They’re going to try to partner with as many people as possible.

Will it move the needle around adherence?  It’s still too early to tell.  But, it’s great to see pharma testing new strategies and working in new ways with payers to try to address this challenge.

CarePass Updates – Medication Adherence and Stress

A few weeks ago, I had a chance to follow-up with Martha Wofford, the VP of CarePass about their latest press release.  This was a quick follow-up interview to our original discussion.  As a reminder, CarePass is Aetna’s consumer facing solution (not just for individuals who they insure) which integrates mHealth tools and data to help consumers improve their engagement and ultimately health outcomes.

“Many Americans have a lower quality of life and experience preventable health issues, adding billions of dollars to the health care system, because people do not take their prescribed medications. There are a myriad of reasons why medication adherence is low and we believe removing barriers and making it easier for consumers to take their medications is important,” said Martha L. Wofford, vice president and head of CarePass from Aetna. “As we continue to add new areas to CarePass around medication adherence and stress, we seek to provide people tools to manage their whole health and hopefully help people shift from thinking about health care to taking care of their health.”   (from press release)

As part of this update, we talked about one of my favorite topics – medication adherence.  Obviously, this is a global problem with lots of people trying to move the needle.  In this case, they’ve included the Care4Today app from Janssen.  This tool does include some functionality for the caregiver which is important.  It also links in charitable contributions as a form of motivation.  We talked about the reality that adherence is really complex, and people are different.  This may work for some, but adherence can vary by individual, by condition, and by medication.  But, they hope that this is a tool that may work to nudge some people.

I was also glad to see them taking on the issue of stress by adding the meQ app.  This is a key struggle, and Martha pointed out to me that 1/4 of adults are either stressed or highly stressed.

“When people are under chronic stress, they tend to smoke, drink, use drugs and overeat to help cope.  These behaviors trigger a biological cascade that helps prevent depression, but they also contribute to a host of physical problems that eventually contribute to early death…” – Rick Nauert, PhD for National Institute of Mental Health, 5/2010

She mentioned that they’ve gotten a great reception to this program, but they have a lot more to learn.  They’re still in the early period of getting insights and interconnecting all of their efforts.  We also talked about some of the upcoming opportunities with the caregivers (or the sandwhich generation).  I personally think the opportunity to improve aging in place through a smart home strategy with remote monitoring is going to be huge of the next 10 years.

I did interview the Janssen people as a follow-up which I’ll post separately, but I also thought I’d include this video interview of Martha that I found.

Express Scripts Excludes 48 Drugs On 2014 Formulary

Is anyone really surprised here?  We saw CVS Caremark make some changes a few years ago that caught everyone’s attention.  (You can see a good list of 2013 and 2014 removals and options here for CVS Caremark.)  This year, it’s Express Scripts (ESRX) who’s caught the attention of the press.

Why do this?  I think Dr. Steve Miller did a great job of explaining it in a recent interview.  The most interesting thing to come out of this was the possible link to copay cards.

Pharmalot: Where to from here?

Miller: We obviously have a long-term strategy. This has sent a loud message to the marketplace that we have got to preserve the benefit for patients and plan sponsors and do things to rein in costs. As there are more products in the marketplace that are interchangeable, we’ll do more to seek the best value for our members. This is just the beginning of a multi-step process over the next several years.

Will there be more to come?  Of course.  The PBMs have to make a significant show of lowering the number of formulary drugs especially in the oral solid (traditional Rx) space to make the point to the pharmaceutical manufacturers that they control market access.  This is critical for them to create more opportunities in the specialty Rx space around rebates.  (Here’s the 2014 Express Scripts exclusion list)

Additionally, this is a low risk strategy for several reasons:

  • The disruption is minimal.  While 780,000 people sounds like a lot, it’s still just 2.6% of the population covered by these formularies.  The savings the employer will generate per disrupted member will pay for the extra customer service needed.  (Harsh reality to some people…I know)
  • As I’ve discussed before, the margins are in specialty pharmacy and mail order generics not in branded drugs which represent less than 20% of all drugs.  Therefore, this is a good place to make a stand.
    • From an old JP Morgan analysis from 2011, Lisa Gill estimated the PBM profits to be (all in 30-day equivalents):
      • $1.69 retail brand drug
      • $2.03 mail brand drug
      • $3.00 retail generic drug
      • $13.00 mail generic drug
  • This is based on a clinical review by an independent P&T committee.  Therefore, this is aligned with the health reform focus on outcomes and value.

New/Old Accusations About PBMs And Their Margins

PBMs (or Pharmacy Benefit Managers) are big business.  Just look at a few of the names and their place on the Fortune 500 list:

Not surprisingly, none of those are non-profits.  There is real money being made here.  It’s all part of the mark-up game in healthcare.  The question of course is does the money being made justify the profits.  For example, I’m happy to pay my banker lots of money as long as he’s earning me more than he’s making (and significantly more).

This is a complicated question.  (see past posts on What’s Next, Why People Don’t Save With Mail, and Growing Mail Order)  I’ve also presented on this topic several times in the past pointing out that the model needs to change, and re-iterating the fact that PBMs made a mistake by putting all their profits in the generic space.  I’ve always said that disintermediation would happen by focusing on generics at mail which is where all the money was at Express Script (8 years ago).  [People remind me that some of this has changed and is different across PBMs.]

The new Fortune article by Katherine Eban called “Painful Prescription” certains shows a dark story.  It focuses exactly on one of these scenarios which is the gap between acquisition cost and client cost.  The article talks about paying $26.91 for a drug but selling it to the client at $92.53.  I’m always reminded of the fact that at one time we used to buy fluoxetine (generic Prozac) for about $0.015 per pill.  On the flipside, we had brand drugs that we bought for more than we got reimbursed and lost money.  It was strange model.

So, here’s my questions:

  1. Do you want transparency?  If so, there are lots of “transparent PBMs” and many larger PBMs will do transparent deals.  You can also follow the Caterpillar model.  (Don’t forget that pharmacy represents less than 20% of your total healthcare spend so you can find yourself down the rabbit hole here trying to shave 2% of spend on 20% or 0.4% of your costs with a lot of effort.)
  2. Are you focused on anamolies like this one or average profits per Rx?
  3. Do you have the right plan design in place?
  4. Do you have a MAC (maximum allowable cost) list both at retail and mail order for generics?
  5. Are you getting the rebates and any admin fees from pharma for your claims passed through to you at the PBM?
  6. If you pay the PBM on a per Rx basis (i.e., no spread allowed), what are they doing to keep your drug costs down year over year (i.e., they have no more incentive to push down on suppliers)?
  7. Are you benchmarking your pricing?  Look at reports from places like PBMI.  For many smaller clients, I often wonder if the savings they find you is worth the costs.

I’m sure there’s more since I’ve been out of the industry for a few years, but while I don’t intend to be the defender of the industry, I do like to bring some balance to the conversation.

7 Steps To Manage Specialty Drugs – From Prime Therapeutics

Prime Therapeutics is a PBM owned by the Blues.  Several years ago, they insourced their specialty pharmacy operations from Walgreens.  This has been part of their transformation which was a result of new leadership under Eric Elliott who used to run Cigna’s PBM.  

As a PBM that’s owned by the Blues, I’ve talked about them before as an interesting cross of a standalone PBM (ala Express Scripts) and an integrated PBM (ala Humana Rightsource).  

As everyone in the industry knows, the shift in pharmacy has moved from innovator drugs in the traditional space to innovation in the specialty or biopharmaceutical space.  This includes both branded products and biosimilars.  This is critical path for employers, payers, and PBMs.  

A traditional strategy of promoting generic drugs and mail order or preferred pharmacies just doesn’t cut it anymore.  Although specialty drugs are still only used by about 1% of the population, they are the fastest growing area in healthcare.  According to Prime Therapeutics Drug Trend Report, their clients saw a 19% increase in specialty spending last year.  And, specialty drugs now account for over 30% of all the drug spend.  

If you look at the drug pipeline, this is going to continue to explode.  I just met with a series of specialty pharmacies to discuss their offerings and strategies.  There are several drugs coming that claim to “cure” some of these specialty conditions are at least meaningfully impact the patient outcomes in ways that weren’t even envisioned years ago.  And, I think we all know that’s not going to come cheap!

So, tomorrow (10/10/13), Prime is releasing a new report – “Specialty: Today & Tomorrow” which highlights Prime’s specialty drug trend over the past year and recommends strategies that high-performing plans use to manage the steady rise in these costs.  [My comments in brackets.]

1.        Bridge the benefit divide: use combined pharmacy and medical benefit data to see the full scope of specialty spending and seek solutions.  [Critical.  IMO – No one is doing this well yet, but this is something that everyone’s trying to figure out.]

2.        Focus on the biggest issues: use combined data to target the most urgent issues and focus on the areas that can provide the greatest return on investment.  [I’d expand this to be an integrated set of data – medical, pharmacy, lab, patient reported, EMR, etc.  This has to then be integrated with tools for depression screening and others to make sure the patient is supported.]

3.        Narrow the specialty network: use cost-effective distribution channels and limit the number of distributors to secure lower prices. [Fairly obvious.  I think many people are doing this.  I would expand on this to include looking at site of distribution for savings.]

4.        Embrace a management mindset: make sure the right specialty drugs are used properly by those who will benefit the most. [Agree.  I’ve talked about this before.  Some of these drugs still have huge adherence issues which limits their effectiveness leading to massive cost issues.  This is why some people are using only 14-day fills.]

5.        Promote preferred drug use: build plans that encourage desired behaviors. [I think we’re finally at a point where we’ll see specialty formularies, more rebating, and with bio-similars there may be more utilization management programs.]

6.        Protect members from high costs: limit members’ out-of-pocket costs and use available tools to reduce the burden on highly vulnerable members. [Critical.  The specialty pharmacy has to help the member limit their financial exposure.]

7.        Pick the right partner: select a trusted advisor with comprehensive capabilities and deep connections to help anticipate and address specialty drug challenges.  [Agree.  An aligned philosophy and strategy to work with these critical patients is fundamental.  This small group of patients drives most healthcare costs.] 

A copy of the specialty report is now available on Prime’s website and short videos about each of the seven steps can be found on Prime’s You Tube channel. This new report is the first specialty-focused report published by Prime. It follows Prime’s 2013 Drug Trend Insights infographic released in May. Visit the Industry Insights of Prime’s website for more drug trend information. 

OMG – Prescription Coupons Could Cost Consumers More

Talk about an article that seems a few years late to the party…

Anyways, I was reading a link from the PCMA today about an article on philly.com about copay cards.  It stresses several points:

  • The cards are typically only for 90-days.
  • The cards get people started on brand drugs not generics.
  • People are less likely to switch to generics after they use the brand.
  • This costs people more money over time.

I’ve talked about copay cards many times and presented on this topic at the PCMA conference a few years ago.

Let me give some quick thoughts here.

  1. The cards may typically be for only 90-days, but most people that drop off therapy or titrate to other strengths do so in the first 90-days so perhaps this is saving some money.
  2. Of course, it’s for brand drugs not generics.  That’s the business model we’ve created in this country where generics are priced at pennies so there is no marketing to support those products.  It’s the PBMs and pharmacies that do the marketing for generics since they are the ones making money here.
  3. I think it’s a fair generalization that people are less likely to switch, but this is the problem.  If the drugs are the same (per the FDA), why is this an issue?  Is it an educational issue.  Or, is there really a difference?
  4. I’m not sure the consumer cost is the issue.  That’s marketing 101.  Don’t most consumers understand this issue that sales and coupons drive you to build loyalty often to higher priced products.  I think the debate here needs to stay on the payer who pays 70-80% of the drug costs.  They are the ones who really have an issue here since they don’t control the decision made in the market.

This one doesn’t seem to be going away, but I’m not seeing any net new information.

94% of Cancer Doctors Say Patients Affected by Drug Shortages

This seems like the type of headline you’d expect to see in a 3rd world country not the US.  But, we’ve been talking about drug shortages for years, and while it may be better in a few areas, cancer isn’t one of them.

I was recently reminded of this in an AJMC article which was discussed at ASCO and had this data point about 94% of oncologists and hematologists from a University of Pennsylvania study.  

Looking back a few years, I think IMS did one of the best studies on this topic.  Here’s a few of the items they highlight from the study (with links to their charts).

It can be a little mind-boggling.

  • Is it an issue of planning and forecasting demand?
  • Is it an economic issue of not enough profit in these drugs?
  • Is it an issue of quality where these get shut down due to manufacturing issues?
  • Is it a structural issue of too few suppliers?
  • Is it a raw materials issue?

Pharmacy Non-Adherence Infographic

While I’ve moved most of the infographics I find to my Pinterest account, I wanted to capture and share this one from Stephen Wilkin’s blog since it hits so many of the points that I try to make with people.

patient-non-compliance-infographic3

Could Generic Prescriptions Be The Greatest Placebo Ever?

Those of you who know me know that I’ve been a huge advocate for generic prescriptions since the early part of my PBM/pharmacy career in 2001. It wasn’t long ago that I talked about unresponsible reporting when slamming generics and scaring the population. But, we all enjoy a good conspiracy theory which is about the only thing that makes sense reading the new Fortune article – Dirty Medicine – about Ranbaxy. Both articles are written by the same author, but this one scares me a lot more than the other one. This article reads like a fiction book but appears to be true.  It should scare you also and put a spotlight on the FDA.

Here are a few things from the article.

On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn’t meet specifications, and making intentionally false statements to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties — the most ever levied against a generic-drug company.

The company manipulated almost every aspect of its manufacturing process to quickly produce impressive-looking data that would bolster its bottom line. “This was not something that was concealed,” Thakur says. It was “common knowledge among senior managers of the company, heads of research and development, people responsible for formulation to the clinical people.”

It made clear that Ranbaxy had lied to regulators and falsified data in every country examined in the report. “More than 200 products in more than 40 countries” have “elements of data that were fabricated to support business needs,” the PowerPoint reported. “Business needs,” the report showed, was a euphemism for ways in which Ranbaxy could minimize cost, maximize profit, and dupe regulators into approving substandard drugs.

But, we know that generics have worked. People have gotten better so one has to assume this isn’t a massive fraud especially when 50% of generics have traditionally been made by the brand manufacturers themselves who would never risk their companies to do what Ranbaxy did. So, it made me wonder about the Placebo Effect. Did some drugs work simply because of that?  Is there anything else that would make sense for why this wasn’t discovered more quickly?

I’ve talked a lot about the Placebo Effect. There’s now even an app to make you feel better using the Placebo Effect.

I’m shocked that the PBMs, pharmacies, manufacturers, associations, wholesalers, and others aren’t out talking about this.  I would want to let the public know that this isn’t a systemic problem, but is one contained to one instance and that quality will be maintained…but maybe no one cares?

Why Do People Think Adherence Is So Easy?

I think we all know that medication adherence is a big deal. The most common number quoted is the $290B waste number from NEHI. There are numerous studies that confirm the value of non-adherence even one that just came out.

The amount of money spent on trying to improve adherence is huge! Pharma has worked on. Retail pharmacies have worked on it. Providers have worked on it. Insurance companies have worked on it. Employers have worked on it… And all of these have happened across the world.

At the same time, you see people get so excited about things don’t make any sense to me.

Let me take an easy example. A few months ago, a company called MediSafe put out a press release around moving medication adherence on statins up to 84.25%. Nothing against the company, but I read the press release and reached out to them to say “this is great, but it’s only 2 months of data…most people drop therapy after the first few months so who care…call me back when you get some good 12 month data.”

But, a lot of people got all excited and there was numerous press about this – see list of articles about them.

Now, tonight, I see another technology getting similar excitement. Fast Company talks about the AdhereTech technology which integrates a cellular phone with a pill bottle. And, it costs $60 a month. In my experience, companies wouldn’t even spend $2 a month to promote adherence so $60 is just impractical. The argument is that this is good for high cost specialty drugs that are oral solids not injectables. But, this isn’t a new idea. Glowcaps already built this model with a very slick interface and workflow.

And, I don’t know about you, but I think this would be obnoxious. And, I love data and am part of the QuantifiedSelf movement. I’m not sure I understand the consumer research here. I would have to believe all of the following to buy into this model.

  • Non-adherence people are primarily not adherent due to no reminders to take their medication on a daily basis.
  • People with chronic conditions that require high cost specialty drugs are going to change behavior because some bottle sends them a text message.
  • Manufacturers or some other healthcare company is willing to pay $60 a month for this service.
  • There won’t be message fatigue after a few months (weeks) of messaging.
  • Pharmacies would be have to be willing to change their workflow to use these bottles.

Yes. Will this work for some people…sure. But, if it helps 10% of people, then my cost is really $600 per success.

Should we be working on better solutions to address adherence…of course.

But, let’s stop trying to figure out some gimmick to fix adherence. Let’s look at root cause.

For example:

  • People don’t know why they’ve been given a medication.
  • People don’t understand their disease.
  • People can’t afford their medication.
  • People don’t know what to expect in terms of side effects.
  • People don’t see value in improving adherence.
  • People don’t know they have to refill their medications.
  • People aren’t health literate.

We have a lot of problems.

2013 PBMI Presentation On Pharmacy Need To Shift To Value Focus

Today, I’m giving my presentation at the PBMI conference in Las Vegas.  This year, I choose to focus on the idea of shifting from fee-for-service to value-based contracting.  People talk about this relative to ACOs (Accountable Care Organizations) and PCMHs (Patient Centered Medical Homes) from a provider perspective.  There have been several groups such as the Center For Health Value Innovation and others thinking about this for year, but in general, this is mostly a concept.  That being said, I think it’s time for the industry to grab the bull by the horns and force change.

If the PBM industry doesn’t disintermediate itself (to be extreme) then someone will come in and do it for them but per an older post, this ability to adapt is key for the industry.  While the industry may feel “too big to fail”, I’m not sure I agree.  If you listened the to the Walgreens / Boots investor call last week or saw some of things that captive PBMs and other data companies are trying to do, there are lots of bites at the apple.  That being said, I’m not selling my PBM stocks yet.

So, today I’m giving the attached presentation to facilitate this discussion.  I’ve also pre-scheduled some of my tweets to highlight key points (see summary below).

 

Planned PBMI Tweets

Why We Need Whole Patient Adherence Programs

While prescription adherence continues to be a $290B+ problem, we still address the problem in a drug by drug approach due to silos within our healthcare value chain.

For example:

  • Generic drugs (about 80% of the prescriptions filled) are the lowest cost and most profitable drugs (to the suppliers).  For these medications, you’ll usually have several programs:
    • Refill reminder calls, text messages, letters
      • From the PBM
      • From the retail pharmacy
      • From the mail pharmacy
  • Auto-refill programs
  • Brand drugs are usually higher cost and profitable (to the manufacturers).  For these, you have pharma funded programs such as:
    • Messaging attached to your bill at the pharmacy
    • Letters sent to your house by the pharmacy
    • Specialty drugs which are the highest cost and typically profitable (across the supply chain).  For these, companies often take a higher touch approach:
      • Pharmacy techs calling you
      • Nurses calling you

Additionally, there is additional effort made to keep you adherent if:

  • You’re a Medicare Advantage member in one of the categories where adherence is measured for the STAR metrics program
  • You’re have a condition where adherence is a key metric for HEDIS or some other quality program

For those of us that have studied adherence, you know that this is a multi-factorial issue meaning that there are numerous things that impact your adherence.  Some people will respond to nudging.  Some people need to better understand their disease.  Some people need co-pay relief or patient assistance programs.  Some people need a different medication.

But, the two things we don’t need are:

  • Being treated like a disease not a patient
  • Getting 4, 5, 10 different communications from different parties on different schedules

So, what’s the answer.  There isn’t a silver bullet (which is what we’d all like).  I believe the best alternative is to drive adherence through the disease management and case management companies.  These nurses are treating the patient.  They are discussing their multiple co-morbidities with them.  They are talking about and understanding their barriers.  They should be able to help “prescribe” information and tools to help them with their adherence.

Of course, the issue here is engagement.  If we’re only getting 10% of the patients with chronic illnesses to participate in our programs (which is about the national average – I believe), what about the other 90%.  This is where a care coordination program that incorporated the provider and the pharmacy into a technology solution which pushed gaps-in-care and messaging through the EMR and pharmacy system to drive coordinated solutions is the answer.

I don’t know when this will happen, but I don’t believe we’re going to put a dent in adherence until we think differently about this problem.

CVS Caremark Adherence Study – Is Facebook The Solution To Adherence?

A new study funded by CVS Caremark as part of their ongoing research into medication adherence was recently published.

“Association Between Different Types of Social Support and Medication Adherence,” December 2012 issue of American Journal of Managed Care

In this, researchers reviewed 50 peer-reviewed articles about studies which directly measured the relationship between medication adherence and four categories of social support, including:

  • Structural support – marital status, living arrangements and size of the patient’s social network
  • Practical support – helping patients by paying for medications, picking up prescriptions, reading labels, filling pill boxes and providing transportation
  • Emotional support – providing encouragement and reassurance of worth, listening and providing spiritual support
  • Combination support – any combination of the three support structures detailed above

According to the study, greater practical support was more often linked to improved medication adherence, with 67 percent of the studies evaluating practical support finding a significant association between the support and medication adherence.

It drives some interesting questions as you dig into the actual research.  I sent several questions to Troyen A. Brennan, MD, MPH, who is the Executive Vice President and Chief Medical Officer of CVS Caremark, and heads the research initiative that conducted the study.  Here are his responses:

1. How will this research change CVS Caremark’s approach to medication adherence such as your Adherence to Care program? 

CVS Caremark’s Adherence to Care program is all about engaging patients more consistently and directly to ensure they are following their medication regimes. We understand that our patients’ social networks and communication preferences are diverse, and we know that multi-dimensional interventions help to change behaviors. Given these factors, this research can be an important reference point as we develop new approaches to our adherence programs, challenging us to look beyond traditional engagement strategies in an effort to most effectively support patients on their path to better health. We are planning to test some interventions along these lines in 2013.  As a pharmacy innovation company, we want to make sure we are anticipating patient needs and remaining relevant to them especially given the changing face of social communication and networks.  

2.  The data points required to assess these support factors aren’t readily available in the eligibility file or claims file.  Are you collecting that data at the POS or during the enrollment process and using it in any way to determine the correct intervention cadence or level of effort at an individual level?

While this may not be the standard today, it is clear from the research that a patient’s social network and resulting support can be important factors in helping them take their medications as directed. This research can help us and others in the industry think about how best to incorporate new approaches to identify and leverage social networks for greater medication adherence.  For now, we will rely on POS as a way to collect this type of information.

 

  • 3.  To me, it appeared the data was less conclusive than I would like.  There were lots of conflicting data points and qualitative data.  Do you plan to refine this testing within your population to look at differences across disease states and relative to other factors?

 

This study relied on a comprehensive analysis of current literature linking medication adherence to social support networks – so we recognize that there are limitations in being able to draw concrete conclusions on certain factors, such as disease-specific conditions. Regardless, we still believe these findings – which look at clinical, peer-reviewed studies – contribute to the knowledge base in our field. As with all of the research we conduct, we challenge our teams to consider how we might be able to use the information to find practical supports for patients, while at the same time contributing to awareness about the implications of adherence on the broader health care landscape. The best way to understand this research is as hypothesis generating, which we can use in the design of real interventions that we can then test definitively in subsequent studies.

4.        Some of these social factors might be correlated with depression.  Was there any screening done to look at how depression as a co-morbidity might have affected adherence rates?

The methodology of this study relied on literature review and analysis of fifty peer-reviewed research articles which directly measured the relationship between medication adherence and forms of social support. A full review of the medical conditions associated with these studies can be found in Appendix 1. While depression, alone, was not one of the conditions featured in these studies, several did look at mental health conditions and the linkage between adherence and social networks. We did not however stratify by existence of depression—it may be a factor we have to take into account in future studies.

5.   The one thing that I read between the lines was the need for a caregiver strategy.  This has been missing in the industry for years.  Does CVS Caremark have an approach to engaging the caregivers?

 

Our study found that practical support such as picking up prescriptions, reading labels and filling pill boxes – all within the realm of a given caregiver’s role – were the most significant in driving greater adherence. Considering this finding, and acknowledging the role caretakers have in the lives of our patients, there is certainly space for us to develop solutions that engage caretakers more effectively. Recent analyses of “buddy” programs do suggest such interventions do work- -we just need to consider how to scale it.

 

  • 6.        With all this talk about social networks, it naturally leads you to a discussion about Facebook (or Google+).  Neither of them have big focuses in the healthcare space.  In your opinion, will these tools offer an intervention approach for changing behavior around medication or will that be occur at the disease community level in tools like PatientsLikeMe or CureTogether where there’s no social bond but a connectivity around disease? 

 

 The role of social media has changed the way we communicate and connect with one another dramatically over the past decade. What we can say, based on this particular study, is that the more practical the support, the more significant the impact on medication adherence. Perhaps further studies looking into solutions that effectively combine online/social media platforms to complement practical support would help clarify their impact on medication adherence.

If interested, here are some of their other presentations on adherence:

How Farmers Outmarketed Pharma

When you think of potatoes, where do you want them to come from? Idaho

When you think of citrus, where do you want it to come from? Florida

When you think of US wine, where do you want it to come from? Napa Valley

When you think of generic drugs, where do you want them to come from? [company?, geography?]

This vacuum is a big problem in terms of commoditization. People don’t think of Teva or Ranbaxy or some other generic company. The average consumer probably doesn’t know who they are. And, they’ve competed based on price for years. If I was the CEO of Teva, this would be the number one challenge I would pose to my staff which was how do I get consumers to ask for my generic version of the drug. The next question should be what would we do to justify this?

For the first time, I think that they have a similar problem that brand pharma does which is how to create an offering not just a pill. The quote below from the CEO of Novartis, tees it up well.

“I also started to shift our business away from a transactional model that was focused on physically selling the drugs to delivering an outcome-based approach to add value beyond just the pill. I really believe that in the future, companies like Novartis are going to be paid on patient outcomes as opposed to selling the pill.”

And, I think this reflects what Sanofi has been experimenting with in terms of diabetes for several years. They launched their iBG Star Blood Glucose Meter to get into the meter space. Sanofi also has heavily invested in social media to give them direct engagement and feedback from consumers. Both of these begin to create more consumer branding for them as an entity.

I’ve talked about this several times over the years based on a book that one of the E&Y partners wrote when I was there called BLUR which was about blending products and services to create offerings. I think this notion combined with the lessons learned that commodities like potatoes have gone through in branding their products offer some insights into what pharma has to do to shift their positioning in the value chain. This is part of what I’ll be discussing at the upcoming PBMI conference where this shift to outcomes based contracting and focus for the industry is critical to long-term survival and differentiation.

How To Improve Good Cholesterol (HDL) If Drugs Don’t Work

The Wall Street Journal on 1/8/13 had an article called “New Rules for Boosting Good Cholesterol” which shared the results of a recent study on medications that improve HDL (or Good Cholesterol).

“Not all HDL are created the same” was what Roger Newton, chief science officer of Esperion said.

“If you raise HDL in non-pharmacologic ways, it really does help you” says Steve Kopecky, a Mayo Clinic cardiologist.

The points made in the article can be summarized in the following:

  • Improving good cholesterol is important.
  • People with high HDL face fewer heart attacks (according to the Framingham Risk Score)
  • Multiple trials to improve HDL with drugs have failed
  • People may need to raise good cholesterol by behavior change

This should lead to 3 questions:

  1. What should be my HDL or Good Cholesterol? From the Mayo Clinic on Good Cholesterol:

  1. What can I do to improve my Good Cholesterol without drugs? From the WSJ article:

Activity

HDL Increase

Exercise

4 mg/dL

Drink Alcohol (in Moderation)

2-4 mg/dL

Quit Smoking

5 mg/dL

Lose Weight

1 mg/dL per 3-6 lbs

Eat Fish And Olive Oil

3-5 mg/dL

Avoid Carbohydrates

8 mg/dL

  1. What are my risks and the value of medications? For that, I found two online risk tools.

Here’s a simple one that uses the Farmingham study to estimate your risk of having a heart attack.

Here’s another one from over in Europe that’s focused on the value of statins and hosted by the Cleveland Clinic. It takes more inputs but then gives you several outputs. (A nice algorithm to integrate with something like iBlueButton or your care management system perhaps to warn you of risks without having you input a bunch of data.)

Court Decision Allows Pharma Reps To Discuss Off-Label Uses Of Prescriptions

I must admit that I’ve heard very little about this decision from the Federal Appeals Court for the Second Circuit of Manhattan that decided that discussing off-label uses for prescription drugs was an issue of free speech. This could change the way pharmaceutical manufacturers interact with physicians. It could change the job of the pharmaceutical rep. It could change how clinical trials are done. It could change how prescriptions are used. It could also lead to a whole new set of prior authorizations by companies that actually have to actively manage off-label usage as it becomes widespread.

On the other hand, I wonder if this door hadn’t already been opened. Have you looked at some of the peer-to-peer (P2P) healthcare websites out there or the disease based communities (e.g., PatientLikeMe or CureTogether)? Patients are already talking about what medications they are using to treat their diseases and their symptoms. Don’t you think those are leading to requests to the provider and discussions with them about off-label utilization?

And, I’m sure that Dr. Google has helped many patients identify other uses of medications. This process (to the best of my knowledge) is completely un-managed. It’s a popular enough topic that Consumer Reports talked about it earlier this year and even put together the following table on drugs commonly used off-label.

Specific drug, type of drug Examples of off-label use**
Aripiprazole (Abilify), antipsychotic Dementia, Alzheimer’s disease
Tiagabine (Gabitril), antiseizure Depression
Gabapentin (Neurontin), antiseizure Nerve pain caused by diabetes, migraines, hot flashes
Topiramate (Topamax), antiseizure, in combination with phenteramine for weight loss Bipolar disorder, depression, nerve pain, alcohol dependence, eating disorders
Risperidone (Risperdal), antipsychotic Alzheimer’s disease, dementia, eating disorders, post-traumatic stress disorder
Trazodone (Desyrel), antidepressant Insomnia, anxiety, bipolar disorder
Propranolol (Inderal), high blood pressure, heart disease Stage fright
Sildenafil (Viagra), erectile dysfunction To enhance sexual performance in people not diagnosed with erectile dysfunction, to improve sexual function in women taking certain antidepressants
Quetiapine (Seroquel), antipsychotic Dementia, Alzheimer’s disease, obsessive-compulsive disorder, anxiety, post-traumatic stress disorder
SSRI antidepressants such as paroxetine (Paxil) and sertraline (Zoloft) Premature ejaculation, hot flashes, tinnitus (ringing in the ears)
Prazosin (Minipress), high blood pressure Post-traumatic stress disorder
Amitriptyline (Elavil), antidepressant Fibromyalgia, migraines, eating disorders, pain after shingles infection
Bevacizumab (Avastin), certain types of cancer Wet age-related macular degeneration (eye disease)
Statins such as atorvastatin (Lipitor), simvastatin (Zocor), high cholesterol in adults, children with an inherited cholesterol condition Rheumatoid arthritis, to lower cholesterol in children who lack the inherited condition
Clonidine (Catapres), high blood pressure Smoking cessation, hot flashes, attention deficit/hyperactivity disorder (ADHD), Tourette’s syndrome, restless legs syndrome

* Not meant to be a comprehensive list. Many of the drugs listed here are also available as generics.

** Does not imply that use is clinically appropriate or inappropriate, or beneficial or not.

***To find out if a drug’s off-label use is supported by evidence, click on the medication name.

 

I would imagine that pharma is going to tip-toe through this open door not simply crash through it. They’re generally risk adverse so their discussions of off-label utilization will be fact-based (to limit exposure) even if (as we all know) statistics can lie. I would suspect (as I’ve seen on other blogs) that this will ultimately go to the Supreme Court before anyone really takes advantage of it.

I guess I’d also point to the issue that physicians have responsibility here. They prescribe off-label today. Here’s what the FDA says about this:

Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects. Use of a marketed product in this manner when the intent is the “practice of medicine” does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.

One way to begin to manage this would be to require the use of diagnosis codes (Dx) on all prescriptions. This would at least great a way of tracking how the medications are being used and allow for better technology oversight across the provider, payer, pharmacy, and PBM.

In the interim, Consumer Reports suggest consumers do the following:

  • When your doctor prescribes a drug, ask if it’s an approved use. If he or she doesn’t know, ask your pharmacist.
  • Check for yourself. Go to DailyMed (dailymed.nlm.nih.gov/) and search for the drug. Then click on the tab for “Indications & Usage” to see if your condition is listed.
  • If it’s an off-label use, ask your doctor if it’s supported by well-designed trials showing significant improvement for people with your condition.
  • Ask your doctor why he or she thinks the drug will work better than approved drugs for your illness.
  • Find out if your health insurer covers payment for the off-label use. Some may require evidence of effectiveness or failure with conventional treatments, especially if the drug is expensive.

Retail Pharmacy Mobile Applications

I’ve talked before about some of the mobile PBM efforts, but what about the retail pharmacies. You should expect that the chains will have different mobile strategies than the grocery stores or the big box retailers. And, it will be interesting to see how the independents might collaborate on a shared platform.

Here’s a few things already out there:
Walmart new shopping application and Walmart’s page on mobile
CVS retail application
Walgreens has a mobile pharmacy app
Target also has a mobile pharmacy application

So what should or could pharmacies offer consumers in terms of mobile applications:
– A refill application is a minimum
– Education or drug information is another basic
– There are certainly some geographic options such as a store locator or clinic locator
– There are options for location based check-in using Foursquare
– Scheduling MTM consultations or vaccinations are a reasonable option
– What about promoting saving thru 90-day retail or generics?
– As retail pharmacies are in the specialty business, there could be opportunities to promote this channel and offer support.
– Telemonitoring is another option (e.g., FaceTime)
– Use of QR code is another part as is augmenting the shopping experience with augmented reality
– Of course, couponing will be part of the solution, but what I’d like is someone who would download my shopping receipts (from multiple companies) and provide me with relevant savings.
– Should it include Rx coupons? Unlike the PBMs, retailers want traffic and if coupons increase adherence then why not.
– There are other options like photos and integration with social networks and tools.

I think one of the key “killer apps” is secure rules based messaging. Imagine using data to identify when you need a vaccination or identifying a potential drug-food issue or having age based triggers. These could be sent directly to the consumer in a secure environment. Of course, we’re only at about 10% adoption and the key question is whether these are the key consumer that everyone wants to attract. Are they the high utilizers? Do they buy other goods?

More to come here. This is a rapidly evolving space.

%d bloggers like this: